Sanofi and Regeneron Pharmaceuticals, Inc. have announced that the U.S. Court of Appeals for the Federal Circuit has ordered a new trial and vacated the permanent injunction in the dispute concerning Amgen’s asserted patent claims for antibodies targeting PCSK9 (proprotein convertase subtilisin/kexin type 9). This ruling means that Sanofi and Regeneron will continue marketing, selling and manufacturing Praluent^® (alirocumab) injection in the U.S.

In the decision, the Federal Circuit ruled that the trial court erred by (1) Excluding evidence regarding written description; (2) Excluding evidence on enablement; (3) Improperly instructing the jury on written description, holding that the law requires "a written description of the invention", meaning the claimed antibody itself and not the antigen; and (4) Improperly granting a permanent injunction. The Federal Circuit affirmed the trial court’s ruling that Amgen’s patents were non-obvious, which was one of Sanofi and Regeneron’s several challenges to validity of Amgen’s patents. Because of the improper exclusion of evidence, the court considered the record to be incomplete and concluded at this time that Sanofi and Regeneron are not entitled to judgment as a matter of law (JMOL) on the issues of written description and enablement.

The schedule for the new trial has not yet been determined. The companies do not anticipate any new trial proceedings to start in 2017.

"We are pleased with the Federal Circuit’s decision to remand for a new trial that allows us to present our complete evidence to the jury," said Karen Linehan, Executive Vice President and general counsel, Sanofi. "It is our longstanding position that Amgen’s asserted patent claims are invalid, and we remain confident in the long-term availability of Praluent for patients."

Praluent was the first PCSK9 antibody to be approved for use in the U.S. It is indicated for use as adjunct to diet and maximally-tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of "bad" (LDL) cholesterol. Praluent is the only PCSK9 antibody that offers two biweekly doses (75 mg and 150 mg) with two levels of efficacy, allowing healthcare providers the flexibility to adjust the therapeutic dose based on their patient’s LDL cholesterol-lowering needs. Praluent is also available as a 300 mg, once-monthly dosing option (every four weeks) in the U.S. The effect of Praluent on cardiovascular morbidity and mortality has not been determined.

"We continue to believe that the law and facts support our position, and we look forward to presenting our complete evidence at trial to a new jury," said Joseph J. LaRosa, Senior Vice President, General Counsel and Secretary, Regeneron. "Praluent represents an important medical advancement for patients, and we remain confident in the meaningful value that Praluent provides not only to patients, but to the overall healthcare system."